. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/160 
14 June 2006 
 (06-2878) 
Committee on Technical Barriers to Trade Original:   English/ 
 French 
 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   CANADA  
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Department of Health 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:    
Canadian Enquiry Point 
200-270 Albert Street Ottawa, Ontario Canada, K1P 6N7 Tel:  (+1) 613 238 3222 
Fax:  (+1) 613 569 7808 
E-mail:  info@scc.ca
 
3. Notified under Article 2.9.2 [  X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:         
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.  
ICS numbers may be provided in addition, where applicable):   Prescription status of 
medicinal ingredients for human use (ICS:  11.120) 
5. Title, number of pages and langua ge(s) of the notified document:   Proposed Amendment 
to the Food and Drug Regulations (Project No. 14 31 - Schedule F) (4 pages, in English;  
5 pages, in French). 
6. Description of content:   This notification announces th e availability of a letter that 
provides an opportunity to comment on the propo sed addition of a medicinal ingredient to 
Part I of Schedule F to the  Food and Drug Regulations . 
Description of the medicinal ingredient: 
1. Quinine and its salts and derivatives :  Quinine is a medicinal ingredient that was 
originally made from the bark of several species of the cinchona tree and was used 
for centuries as the primary treatment for ma laria.  The use of quinine as a malaria 
treatment declined over the years as new sy nthetic derivatives of the drug such as 
chloroquine and mefloquine were develope d and used.  However, with increasingly 
drug-resistant strains of malaria appearing,  there has been renewed interest in the 
use of quinine to treat malaria.  Quinine is now being prescribed for oral use in 
combination with other drugs such as th e antibiotics doxycycline and clindamycin 
to treat non-severe malaria infections caused  by specific organisms that are resistant 
to other anti-malarial drugs. G/TBT/N/CAN/160 
Page 2  
 
  The use of quinine to treat malaria requires individualized instructions and/or direct 
practitioner supervision.  There is a narrow ma rgin of safety between the therapeutic and 
toxic doses of quinine, especially in populations  such as seniors, children, pregnant women 
or nursing mothers.  There are potential or known undesirable or severe side effects at 
normal therapeutic dosage levels that woul d need to be managed by a practitioner. 
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associated  with this medicinal ingredient.  Oversight by a practitioner is 
necessary to ensure that appropriate risk/benef it information is consid ered before the drug 
containing the medicinal ingredient is administered and that the drug therapy is properly monitored. 
Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections 
C.01.041 to C.01.049 of the Food and Drug Regulations .  Part I of Schedule F lists 
ingredients that require a prescription for human use and for veterinary use.  Part II of Schedule F lists ingredients that require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   Therapeutic Products Directorate (TPD) website:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legisl ation/acts-lois/notice-avis/index_e.html , 
Project 1431 letter posted:  30 May 2006 
9. Proposed date of adoption:  Normally within 6 to 8 months from the posting of the 
letter on the TPD website.  
Proposed date of entry into force:  On the date the measure is adopted.  
10. Final date for comments:   13 August 2006 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
The electronic version of Project No. 1431 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1431_e.html